Clinical Operations Director

We are seeking a Clinical Operations Director who will oversee and ensure the successful completion of all clinical operations activities, including study site and CRO management, study budgets, timelines, and deliverables in compliance with SOPs, GCPs and ICH guidelines. 

Job Duties and Responsibilities:

• Execute domestic clinical trials with guidance of senior management, including Phase 3 trials, and ensure studies follow protocols, Standard Operating Procedures (SOPs), ICH/GCP regulations, and study-specific manuals
• Supervise the clinical operations team, including project managers and CRAs
• Provide oversight and ensure performance of CROs and other vendors contracted to support clinical trial activities
• Develop and execute clinical project plans, clinical site engagement plans, and patient recruitment strategies
• Author, review and/or edit clinical study-related documents (e.g., informed consents, Investigator’s Brochures, study materials, essential documents, presentations, IND sections, and reports)
• Develop clinical trial budgets and administer invoices received for clinical trial costs
• Develop Clinical Quality Systems in conjunction with the Quality Assurance team, including drafting SOPs, ensuring CAPA implementation, and preparation for regulatory agency inspections
• Set up a Trial Master File (TMF) system
• Assist with regulatory agency submissions

Education / Experience:

• Minimum BS/BA in scientific, life science, or related field
• 10+ years clinical research experience in the biotechnology/pharmaceutical/CRO industry including 8+ years clinical operations management experience

Qualifications: 

• Firsthand experience in successfully conducting and completing pivotal trial projects leading to regulatory approval
• Experience delivering projects with CRO support of clinical trial activities including proposal review, scope of work analysis, and contract negotiation
• Experience directing and managing clinical research personnel, CROs, and external vendors
• Experience in regulatory submissions to FDA
• Expert knowledge of GCP, ICH Guidelines and other guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.
• In depth understanding of global regulatory and compliance requirements for conducting clinical research including ICH and EMA
• Experience in infectious disease is preferred

Skills:

• Ability to manage, lead, motivate and mentor staff and teams
• Demonstrated ability to remove barriers to success
• Strong organizational and time management skills, and ability to effectively manage and prioritize multiple projects simultaneously
• Able to work in a fast-paced environment
• Ability to professionally interface with senior-level executives, staff, external partners, key opinion leaders, and consultants
• Excellent written, oral and presentation communication skills
• Ability to work independently, take initiative, and meet company goals within timelines and budgets
• Proficient in Microsoft Office (Excel, Word, Outlook, PowerPoint) and project management software (Microsoft Project)